Notably, the draft also reiterates that updates made solely to boost the device’s cyber defenses would not require a 510(k). That approach aligns with a separate draft medical device cybersecurity ...

2021 Draft Guidance. 2025 Final Guidance. Title: Content of Premarket Submissions for Device Software Functions. Title: Content of Premarket Submissions for Software Contained in Medical Devices ...

Software failures were the cause of 24 percent of all the medical device recalls in 2011, according to data from the U.S. Food and Drug Administration, which said it is gearing up its labs to do a ...

In addition to finalized guidance addressing software upgrades, the FDA also released finalized guidance (PDF) on making any type of change to a medical device, as well as draft guidance (PDF) on ...

In 2021, a group of researchers investigating software used in medical devices and machinery used in other industries found over a dozen vulnerabilities that, if exploited by a hacker, could cause ...

Medical device recalls reached record highs in the first three months of 2018 thanks to software complications that are likely to continue with the proliferation of high-tech devices.

Our customer base includes 69 Fortune 500 companies and 57 of the world’s top ER&D companies, across industrial products, medical devices, transportation, telecom & hi-tech, and the process ...

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...

After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part ...

While SaMD, referred to as “medical device software” or “MDSW” in Europe, is patentable, simply stating the use of AI in a technical field is usually not enough to secure a patent.